The purpose of the study is to evaluate the clinical equivalence and the general tolerability of two different subcutaneous hCG preparations (hCG-IBSA, IBSA vs Ovitrelle, Serono) when administered to patients undergoing IVF.
This is a prospective, multicenter, randomized, investigator blind, parallel group, active control, phase III clinical trial. Patients meeting the eligibility requirements of the study will be randomly assigned to receive either the test drug (hCG-IBSA, IBSA) or the reference drug (Ovitrelle, Serono). Investigators will be blinded by not allowing them to have any contact with the study medications (supplied in boxes labeled in a manner that does not reveal the content of the boxes), and requesting that patients do not make any statements to the investigator that might indicate the treatment to which they were assigned. Equivalence testing with regard to the primary outcome variable will establish whether the two treatments are indeed similarly effective.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
144
Department of Gynecology and Obstetrics Universitätfrauenklinik
Basel, Switzerland
4. Department of Gynecology and Obstetrics Frauenklinik, InselspitalEffingerstrasse 102
Bern, Switzerland
Department of Gynecology and ObstetricsUniversity Hospital
Geneva, Switzerland
3. Maternity CHUV - Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Total number of oocytes retrieved per patient who received hCG
Number of patients who received hCG with at least one oocyte retrieved, 2PN fertilized oocytes,
2PN or cleaved embryos, implantation rate per embryo transferred; Serum P and hCG concentration on the days of oocyte retrieval, on day of embryo transfer and on day 5-8 post-hCG;
Implantation rate;Pregnancy rate.
Adverse Events
Adverse events were monitored and collected during all the study period
Time frame: from day 1 to 35 +/- 7 days after oocytes retrieval
Incidence of moderate or severe OHSS
The incidence moderate or severe of OHSS will be assessed in both treatment groups
Time frame: From the day of hCG injection until 35 +/- 7 days after oocyte retrieval
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